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RECRUITING
NCT06672549
PHASE3

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Official title: A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2024-11-18

Completion Date

2027-03

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

DRUG

Orforglipron

Administered orally. ISA specific interventions will be listed in the ISA.

DRUG

Placebo

Administered orally. ISA specific interventions will be listed in the ISA.

Locations (117)

University of Arizona

Tucson, Arizona, United States

Loma Linda University School of Medicine

Loma Linda, California, United States

Childrens Hospital of Los Angeles

Los Angeles, California, United States

UCLA Mattel Children's Hospital

Los Angeles, California, United States

Children's Hospital of Orange County - Orange

Orange, California, United States

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Oxnard, California, United States

Children's Hospital Colorado

Colorado Springs, Colorado, United States

Yale School of Medicine - Yale Diabetes Center (YDC)) Trials

New Haven, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

William A. Shands Hospital at the University of Florida

Gainesville, Florida, United States

Florida Hospital- Center for Pediatric Research

Orlando, Florida, United States

Nemours Children's Health

Orlando, Florida, United States

All Childrens Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States

Ann and Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Norton Children's Endocrinology

Louisville, Kentucky, United States

Velocity Clinical Research

Lafayette, Louisiana, United States

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan, United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

Mayo Clinic - PIN

Rochester, Minnesota, United States

Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center

Saint Paul, Minnesota, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Gulfport, Mississippi, United States

Sundance Clinical Research

St Louis, Missouri, United States

Omaha Childrens Hospital

Omaha, Nebraska, United States

Velocity Clinical Research

Omaha, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

UBMD Pediatrics

Buffalo, New York, United States

UNC Children's Hospital

Chapel Hill, North Carolina, United States

Duke Children's Primary Care

Durham, North Carolina, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Coastal Pediatric Associates

Charleston, South Carolina, United States

Medical University of South Carolina Children Hospital - PIN

Charleston, South Carolina, United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States

Dell Children's Medical Center - PIN

Austin, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

McGovern Medical School

Houston, Texas, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Houston, Texas, United States

La Providence Pediatrics Clinic - Chemidox Clinical Trials

Houston, Texas, United States

Martin Diagnostic Clinic

Tomball, Texas, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

VCU Health - Center for Endocrinology Diabetes and Metabolism

Richmond, Virginia, United States

Seattle Children's Research Institute - Hughes Building - PIN

Seattle, Washington, United States

MultiCare Health System - Mary Bridge Children's Health Center

Tacoma, Washington, United States

UZ Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc - PPDS

Brussels, Belgium

UZ Leuven

Leuven, Belgium

L2IP - Instituto de Pesquisas Clínicas

Brasília, Brazil

Hospital Universitario de Caxias do Sul

Caxias do Sul, Brazil

CPQuali Pesquisa Clínica Sao Paulo

São Paulo, Brazil

National Cheng Kung University Hospital

Tainan, China

National Taiwan University Hospital

Taipei, China

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, China

Yitzhak Shamir Medical Center

Beer Yaacov, Israel

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Azienda Ospedaliero Universitaria Meyer

Florence, Italy

Azienda Ospedaliera Universitaria Policlinico de Modena

Modena, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy

Saitama Medical University Hospital

Iruma-Gun, Japan

Isesaki Municipal Hospital

Isesaki-shi, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

Tokyo Medical Center

Meguro-Ku, Japan

Shiga General Hospital

Moriyama, Japan

Nara Prefecture General Medical Center

Nara, Japan

Osaka City General Hospital

Osaka, Japan

Sagaekiminami Clinic

Saga, Japan

Shikoku Medical Center for Children and Adults

Zentsujichó, Japan

Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC

Culiacán, Mexico

PanAmerican Clinical Research - Guadalajara

Guadalajara, Mexico

PanAmerican Clinical Research - Av. Antea 1032 - PPDS

Juriquilla, Mexico

Centro de Investigacion Farmacologica Del Bajio Sc

León, Mexico

Innovacion y Desarrollo de Estrategias en Salud SA de CV

Mexico City, Mexico

Hospital Angeles Puebla

Puebla City, Mexico

Krakowskie Centrum Medyczne

Krakow, Poland

UMED Clinical Trials

Lodz, Poland

Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie

Rzeszów, Poland

ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej

Stanisławów Pierwszy, Poland

ETG Justmed - PPDS

Warsaw, Poland

Instytut Diabetologii

Warsaw, Poland

FutureMeds - Targowek

Warsaw, Poland

Premium Clinic Wrocław Centrum Medyczne

Wroclaw, Poland

FutureMeds sp. z o. o.

Wroclaw, Poland

Hospital da Luz Lisboa

Lisbon, Portugal

Centro Materno Infantil do Norte

Porto, Portugal

Hospital CUF Porto

Porto, Portugal

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

Málaga, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Spain

Instituto Hispalense de Pediatria

Seville, Spain

Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Bristol Royal Hospital for Children

Bristol, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

Northwick Park Hospital

Harrow, United Kingdom

Hull Royal Infirmary - MAIN

Hull, United Kingdom

Alder Hey Children's Hospital

Liverpool, United Kingdom